Bioequivalence and Bioavailability Forum

Dear Ohlbe

❝ The situation is a bit more complex here. I would still consider the

❝ original document to be the source document, to be archived by the other

❝ CRO. I would not require a signature from the other CRO on the copy you

❝ get or on the fax. However this time I would recommend you to archive your

❝ copy in your study documentation.

❝ However this time I would recommend you to archive your

❝ copy in your study documentation.

We are following this practice. I am very much clear now.

One last doubt:
In CRO, we are using one form for Plasma Sample transfer (from clinical dept to Bioanalytical dept) and this form is filled by both clinical dept and BA dept. Last form entry will be done by bioanalytical dept personal. In this case where to file this form as source document; in Clincal dept or in Bioanalytical dept?

Currently, we are filing this original form in Clinical dept and photocopy (without sign & date by BA dept on photocopy) in BA dept. is this the correct practice?

Once again, are dated signatures needed on the photocopy?

Or shall we file these documents centrally as advised by you in first response without filing the photocopies in BA dept.

Kind Regards,
Preet